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The first subcutaneous injection: Roche's Alzheimer's disease drug received FDA breakthrough therapy designation
Time of Update: 2021-10-22
S. Food and Drug Administration (FDA) as a breakthrough therapy for the treatment of patients with Alzheimer's disease (AD) .
Currently, Roche is conducting two randomized, parallel, placebo-controlled global multi-center phase III key clinical trials of Gantenerumab, GRADUATE 1 and 2.
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The new cell therapy company officially set sail!
Time of Update: 2021-10-22
At the same time, most of the other members of the Xueji biological management team also come from the field of stem cell and cell therapy research, with rich professional experience .
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Has broad-spectrum anti-cancer potential!
Time of Update: 2021-10-22
It has shown strong selective cytotoxicity in a variety of cell lines expressing ROR1 and has shown significant in vivo anti-tumor activity in xenograft mouse models CS5001 is an antibody-conjugated drug (ADC) composed of a human monoclonal antibody targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1) .
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Notice on Public Solicitation of Opinions on the "Catalogue of Reference Preparations of Chemical Generic Drugs (Fiftieth Batch)" (Draft for Solicitation of Comments)
Time of Update: 2021-10-22
Catalogue of Reference Preparations of Chemical Generic Drugs (Fiftieth Batch) (Draft for Solicitation of Comments).
docx"Chemical Generic Drug Reference Preparation Catalog (Fiftieth Batch)" (Draft for Solicitation of Comments).
Application Form for Objection to Reference Preparations of Chemical Generic Drugs.
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What is the "gold standard" of "life-saving drugs" vs. "high-level repetition" for anti-tumor drugs?
Time of Update: 2021-10-22
On August 30, the official website of the State Food and Drug Administration showed that the anti-PD-1 fully human innovative antibody drug sepalizumab (GLS-010) jointly developed by Yuheng Pharmaceutical and WuXi Biologics has been approved for marketing by NMPA for treatment Patients with relapsed or refractory classic Hodgkin lymphoma (r/r cHL) above second-line .
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KRAS inhibitors combined with SHP2 inhibitors for the treatment of lung cancer Mirati and Sanofi reach an agreement
Time of Update: 2021-10-22
Reference materials:Reference materials: [1] Mirati Therapeutics to Collaborate with Sanofi on Phase 1/2 Study Evaluating Combination of adagrasib with a SHP2 Inhibitor in KRAS G12C-mutated Lung Cancer.
aspx[1] Mirati Therapeutics to Collaborate with Sanofi on Phase 1/2 Study Evaluating Combination of adagrasib with a SHP2 Inhibitor in KRAS G12C-mutated Lung Cancer.
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The product pipeline is exciting!
Time of Update: 2021-10-22
Lung cancer field Source: Zai Lab Online R&D Day presentation In addition, he also discussed the unmet needs in the field of gastrointestinal tumors in China , and introduced related product pipelines, including bemarituzumab, margetuximab, TPX-0022, QINLOCK (repatinib), adagrasib and tumor electric field therapy .
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Microchip's Class 1 new drug sitaglipta sodium is about to be approved for type 2 diabetes
Time of Update: 2021-10-22
The results of two phase III clinical trials showed that sitaglipta sodium has an overall good efficacy and safety in T2DM patients with poor blood glucose control through life> .
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Cinda Biological Innovation 2.0
Time of Update: 2021-10-22
Focusing on the strategic goal of global innovation, Cinda National Cleansing Institute will become a powerful engine for Cinda Bio’s new drug discovery, and will focus on building antibody protein engineering technology and immunotherapy platforms, focusing on monoclonal antibodies, polyclonal antibodies, ADCs (including ADC ISAC), T /NK engager, Immuno-cytokine, Pro-drug and Polymeric IgG and other seven cutting-edge technology products .
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[First issue] Kekai Life Sciences received 350 million yuan in Pre-C round of financing to accelerate the advancement of large-scale clinical trials of existing heart valves
Time of Update: 2021-10-22
Artery Network learned for the first time that Kekai (Nantong) Life Sciences Co. , Ltd. (hereinafter referred to as "Kekai Life Sciences") announced that it has received 350 million yuan in Pre-C ro
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BeiGene Baiyueze® approved in Australia for the treatment of Fahrenheit's macroglobulinemia
Time of Update: 2021-10-22
In the ASPEN trial, a total of 101 WM patients were randomly assigned to receive Baiyueze® treatment, and 5% of the patients discontinued treatment due to adverse events, including cardiac hypertrophy, neutropenia, plasma cell myeloma, and subdural hemorrhage .
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Not all innovative drugs have a future
Time of Update: 2021-10-22
In the pharmaceutical industry for more than 20 years, Zhu Xun, who is also a researcher, manager, entrepreneur, and investor with multiple identities, witnessed that after Bi Jingquan took office as Director of the National Medical Products Administration in 2015, the policy began to break the ice, and innovative drugs entered the rapid approval process.
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Some countries use antibiotics and anti-cancer drugs, and Hunan does not open up procurement to the grassroots!
Time of Update: 2021-10-22
2), and the price is not higher than the selected price, apply for inclusion in the monitoring catalog (Among them, Fasudil injection belongs to Shaanxi Drugs selected by the 11-province alliance, non-overrated drugs are temporarily based on the "Notice on Doing a Good Job in the Implementation of the Results of the Selection of Drugs Purchased by the 11-provincial Alliance" (Xiang Medical Insurance Letter [2021] No.
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The stock price has soared!
Time of Update: 2021-10-22
Eid, an expert in the medical field who had held senior management positions at Roche, Merck, Bristol-Myers Squibb and other multinational pharmaceutical companies, updated his status on LinkedIn and officially announced his joining Hengrui U.
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The billion-dollar chronic cough market is vacant, and P2X3 antagonists are here
Time of Update: 2021-10-22
According to the announcement, TCR1672 is a second-generation highly selective P2X3 receptor antagonist, currently mainly used in the treatment of refractory chronic cough (RCC) adult patients in the respiratory field and endometriosis in the pain field and other complex internal organs Pain patients .
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Zhengda Tianqing's first copy of "polymyxin E sodium methanesulfonate" is about to be approved
Time of Update: 2021-10-22
Recently, the listing application (acceptance number: CYHS1700258) of Chia Tai Tianqing's 3 generic drug "polymyxin E sodium methanesulfonate for injection" changed its status in NMPA to "under approval", and the indication was adult hospital-acquired pneumonia.
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How has it been with the US$74 billion acquisition of Xinji to return to the world's TOP10 BMS?
Time of Update: 2021-10-22
With the completion of the acquisition of Xinji by BMS in 2019, the merger of the world's two largest cancer drug companies has given BMS a more significant advantage in the field of tumor immunity .
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Express for the treatment of inflammatory spine disease, AbbVie JAK inhibitor reaches the primary endpoint of two phase 3 clinical trials
Time of Update: 2021-10-22
The patient received a statistically significant reduction in symptoms, including back pain and inflammation, as well as improvements in physical function and disease activity In patients with active ankylosing spondylitis (AS)In patients with active ankylosing spondylitis (AS) 45% of the patients in the upatinib group met the ASAS40 standard, which was significantly better than the placebo group (18%) .
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Brief comment on domestic orthopedics product line
Time of Update: 2021-10-22
With the rise of biological drug R&D and promotion, domestic pharmaceutical companies' R&D for orthopedic products is mainly concentrated in the field of rheumatoid arthritis .
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Trading frenzy in the neuroscience field is repeated, and top venture capitalists join forces with Amgen to establish a new company for US$500 million
Time of Update: 2021-10-22
Amgen announced in 2019 that it would abandon drug research in the neuroscience field, so there are many potential drug molecules in the pipeline for Neumora to choose from .